Keyword

Non-GMP Pharmaceutical Development

Our new state-of-the-art, non-GMP drug product development facility doubles our current pharmaceutical development capacity allowing us to meet the growing demand for the development and scale-up of solid oral dose drug products using a broad range of technologies.

Whereas, our existing GMP facilities support drug product manufacturing from phase I up to registration and commercial scale, the new non-GMP facility primarily focuses on lab-scale experiments, with batch sizes ranging from <1kg up to a maximum of 15 kg scale for most technologies.

The dedicated non-GMP suites mirror all the technical capabilities of our existing GMP pharmaceutical development facility, including high levels of control over environmental conditions as well as extending current capabilities in processing potent compounds with low OELs.

The new non-GMP facility provides a seamless transition between development and GMP phases of projects in early stage development. By deliberately ensuring good integration of all technologies in both the non-GMP and GMP facilities, we can conduct non-GMP work efficiently and transfer rapidly to GMP manufacturing. Essentially speeding up your overall project timeline to clinic, and de-risking the clinical manufacturing activities.

Almac Advantage

Scalability

By deliberately ensuring integration of all technologies in both the non-GMP and GMP facilities, we can conduct non-GMP work efficiently and transfer rapidly to GMP manufacturing for clinical and registration batches.

Scientific Continuity

Integrating your non-GMP development requirements through to early stage clinical development and manufacture, our technical and analytical teams work seamlessly to ensure your requirements are delivered.

Potent Capabilities

Utilising bespoke high containment technology we can assist you in developing and manufacturing highly potent products. Click here to find out more.